Process Engineer (Medical devices)

Location: Yishun Key Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Materials Science, or a related field.

• 5–10 years of hands-on experience in automation and automated assembly, preferably in the medical device or pharmaceutical industry.

• Strong experience in automation systems, robotics, automated assembly, tooling, and fixture design/development.

• Proven ability to lead automation projects from concept to implementation, including equipment qualification and process validation.

• Working knowledge of cGMP manufacturing environments.

• Strong knowledge of assembly process optimization, manufacturing automation, equipment reliability, and process capability.

• Familiarity with U.S. FDA regulations, EU MDR 2017/745, ISO 13485, and ISO 14971 is an advantage.

Job Function

• Lead the Process Engineering team to provide effective support to production and value-stream objectives.

• Drive engineering initiatives to maximize machine uptime, equipment reliability, process capability, yield, output, quality, and OEE.

• Lead automation, equipment upgrade, and assembly process improvement projects.

• Oversee equipment maintenance, preventive maintenance, calibration, and risk assessment activities.

• Lead equipment/process validation and provide the required engineering resources and support.

• Drive continuous improvement and productivity initiatives while minimizing production disruptions.

• Manage engineering resources, budgets, and capital expenditure (CAPEX).

• Collaborate with cross-functional teams, suppliers, subcontractors, other plants, and relevant external parties to improve equipment and process effectiveness.

• Ensure compliance with quality, safety, environmental, and company policies through effective communication, training, and implementation.

Interaction

• Internal: Communicate and collaborate effectively with associates at all levels and cross-functional teams.

• External: Coordinate with other Merit Medical plants, corporate/regional/business teams, suppliers, subcontractors, and government agencies as required.

For interested applicants, kindly send your resume in Word/PDF format to include the following in your resume including:

1. Current Salary
2. Expected Salary
3. Availability
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